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Product NDC Code | 14222-2430 | ||||||||
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Drug Name | Soothe moisturizing rescue cream |
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Type | Brand | ||||||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | CREAM | ||||||||
RxCUI drug identifier | 240651 | ||||||||
Application Number | M016 | ||||||||
Labeler Name | Rodan & Fields | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Colloidal Oatmeal 1 %
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply an even layer over face and neck as needed. Avoid eye area. Use AM + PM after Sensitive Skin Treatment.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua/Eau/Water, Ascorbyl Palmitate, Behenic Acid, Butyrospermum Parkii (Shea) Butter, C12-16 Alcohols, Calcium Gluconate, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide AP, Ceramide EOP, Ceramide EOS, Ceramide NP, Ceramide NS, Ceteareth-25, Cetyl Alcohol, Cholesterol, Curcuma Wenyujin/Curcuma Kwangsiensis Rhizome Extract, Cynara Scolymus (Artichoke) Leaf Extract, Decyl Glucoside, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Hydrogenated Lecithin, Lecithin, Maltodextrin, Ophiopogon Japonicus Root Extract, Opuntia Ficus-lndica Fruit Extract, Palmitic Acid, Panthenol, Phenoxyethanol, Polysilicone-11, Potassium Sorbate, Propanediol, Sodium Acrylates Copolymer, Sodium Benzoate, Tocopherol, Xanthan Gum, Yeast Extract.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema.
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.SOOTHE Moisturizing Rescue Cream OATMEAL OATMEAL OATMEAL ASCORBYL PALMITATE BEHENIC ACID SHEA BUTTER C12-16 ALCOHOLS CALCIUM GLUCONATE N-HEXANOYLSPHINGOSINE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL CERAMIDE AP CERAMIDE 1 CERAMIDE EOS CERAMIDE NP CERAMIDE NG CETEARETH-25 CETYL ALCOHOL CHOLESTEROL CURCUMA KWANGSIENSIS ROOT CYNARA SCOLYMUS LEAF DECYL GLUCOSIDE DIMETHICONE GLYCYRRHIZINATE DIPOTASSIUM EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN GLUCONOLACTONE GLYCERIN SUNFLOWER OIL HEXYLENE GLYCOL HYDROGENATED SOYBEAN LECITHIN LECITHIN, SOYBEAN MALTODEXTRIN OPHIOPOGON JAPONICUS ROOT PRICKLY PEAR FRUIT PALMITIC ACID PANTHENOL PHENOXYETHANOL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) POTASSIUM SORBATE PROPANEDIOL SODIUM BENZOATE TOCOPHEROL WATER XANTHAN GUM YEAST, UNSPECIFIED
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel - 50 mL Carton Label RODAN+FIELDS SOOTHE Moisturizing Rescue Cream 3 50 mL/ 1.7 Fl. Oz. U.S. Colloidal Oatmeal Cream Principal Display Panel - 50 mL Carton Label
Principal Display Panel - 50 mL Tube Label RODAN+FIELDS SOOTHE Moisturizing Rescue Cream 3 Colloidal Oatmeal Skin Protectant Principal Display Panel - 50 mL Tube Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-995-5656
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if Condition worsens. Symptoms last more than 7 days or clear up and occur again within a few days.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not get into eyes.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. When using this product do not get into eyes. Stop use and ask a doctor if Condition worsens. Symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If product is swallowed, get medical help right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API